Orphan drug designation

An orphan drug is a medicine, vaccine or in vivo diagnostic agent that meets the requirements of regulation 16J of the Therapeutic Goods Regulations 1990. 

Orphan drug designations allow for a waiver of application and evaluation fee for registration in the Australian Register of Therapeutic Goods (ARTG).

For information on applying for an orphan drug designation, go to Orphan drug designation.

For information on the eligibility criteria and supporting documentation requirements for orphan drug designation, go to Orphan drug designation eligibility criteria.